BrainScope is an FDA-cleared, handheld, Class 2 medical device that uses artificial intelligence (AI) and machine learning (ML) technology to identify objective biomarkers of structural and functional brain injury in patients with suspected mild traumatic brain injury (mTBI).
BrainScope enables clinicians to triage mTBI at the point of care without radiation and with a demonstrated 30%-60% reduction in unnecessary head Computerized Tomography (CT). BrainScope is appropriate for patients presenting to emergency departments, urgent care centers, and concussion clinics, as well as patients playing sports or in the military. In less than 20 minutes from patient preparation to result, BrainScope provides an easy to use, intuitive tool for the operator and immediately available accurate, actionable results for the medical professional.
“What an honor it is to receive this award from MedTech Breakthrough. This validates the work of our entire team as we strive to improve brain health by providing objective diagnostic insights that enable better patient care,” says Diku Mandavia, MD, chief medical officer at BrainScope. “BrainScope helps answer key clinician and patient questions—whether the patient has suffered a brain bleed or concussion, and whether they are ready to resume normal activities. The technological change that BrainScope brings has immediate benefits to both the patient and the emergency department—the timing of this 21st century approach couldn’t be better.”
The mission of the MedTech Breakthrough Awards is to honor excellence and recognize the innovation, hard work, and success in a range of health and medical technology categories, including telehealth, clinical administration, patient engagement, electronic health records (EHR), virtual care, medical devices, medical data, and many more. This year’s program attracted more than 3,900 nominations from over 15 different countries throughout the world.
“Traumatic brain injuries are at near-epidemic levels in the U.S. with five million head injured patients receiving care in emergency departments each year and while CT remains the standard of care, these scans can only detect the presence or absence of a brain bleed and do not detect concussion,” says James Johnson, managing director, MedTech Breakthrough. “BrainScope is the only system that aids in the full spectrum assessment of mild traumatic brain injuries including brain bleeds and concussion. It is truly point-of-care and takes just minutes from patient preparation to results – a true breakthrough that we are thrilled to recognize in our sixth annual MedTech Breakthrough Awards program.”
BrainScope’s FDA-cleared technology is exceptionally validated, published, and patented, through 29 clinical studies, greater than 14,000 subject evaluations, 8 FDA and 2 Health Canada clearances, MDSAP and ISO13485 certifications, 31 peer-reviewed publications and 90 issued global patents.
BrainScope’s FDA-cleared, EEG-powered algorithms help clinicians rule out brain bleed, assess concussion and concussion severity, and aid in accurate diagnosis and referral along the continuum of care.